Study to Assess the Incidence of Local Oropharyngeal and Laryngeal Adverse Effects of Advair DISKUS 250/50 Mcg BID
Information source: Allergy & Asthma Medical Group & Research Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma; Candidiasis, Oral; Voice Disorders
Intervention: fluticasone/salmeterol DISKUS 250/50 (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Allergy & Asthma Medical Group & Research Center Official(s) and/or principal investigator(s): Eli O Meltzer, MD, Principal Investigator, Affiliation: Allergy & Asthma Medical Group & Research Center
Summary
This Pilot study is designed to explore the rate of local side effects of fluticasone as
delivered by Advair and to determine the best outcome measure to assess these effects. This
study is the initial step, and will be followed by a larger scale study.
Clinical Details
Official title: A Pilot Study to Assess the Incidence of Local Oropharyngeal and Laryngeal Adverse Effects of Advair DISKUS 250/50 Mcg BID as Assessed by the Development of Laryngitis and Oropharyngeal Candidiasis in Adults With Mild Persistent Asthma
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To determine the magnitude of change from baseline to end of study in the Voice Handicap Index (VHI) with Advair® DISKUS 250/50 mcg BID in subjects with mild persistent asthma.
Secondary outcome: 1. Voice Related Quality of Life (VRQOL)2. Inhaled Corticosteroid Questionnaire (ICQ) 3. Reflux Symptom Index (RSI) 4. Videostroboscopy and Determination of Reflux Finding Score (RFS) 5. Voice jitter 6. Voice shimmer 7. Signal to noise ratio 8. Oropharyngeal Candida species culture 9. Oropharyngeal Candida species related symptoms 10. Oropharyngeal thrush on physical exam
Detailed description:
Asthma is a chronic inflammatory disorder of the airways. The inflammation is associated
with bronchial hyperresponsiveness, airflow obstruction, and respiratory symptoms including
wheezing, coughing and chest tightness.
Inhaled corticosteroids are the most effective controller asthma medications. They are
indicated for management of persistent asthma at all levels of severity. They have been
documented to improve symptoms and pulmonary function and reduce exacerbations, need for
quick-relief medications and airway hyperresponsiveness.
Despite their benefits, inhaled corticosteroids have been associated with adverse local
effects. These include oral candidiasis and dysphonia. However, though these risks have been
reported, they have not been carefully studied. The incidence of oral candidiasis in newly
treated subjects and its onset within a carefully monitored timeframe have not been
adequately assessed.
A more overtly undesirable effect is dysphonia. Data on it are usually collected from
spontaneous reports by patients in clinical trials. However, awareness of dysphonia requires
a certain degree of subjective discomfort to initiate the report. Subjective awareness of
dysphonia often varies based on an individuals voice requirements. A singer, for example, is
usually acutely aware of minor voice changes in contrast to someone who does not depend on
voice quality. Nonetheless, voice abnormalities can probably occur with similar frequency in
patients who are concerned or not concerned with their voice due to inhaled corticosteroids.
New subjective scales for reporting on an individual’s voice have recently been validated
and published in other areas. These scales have not been validated in patients with asthma
or in subjects using inhaled corticosteroids. New technologies for objective voice
assessment have also been developed and these permit greater ability to quantify voice
changes. These advances permit better measures of the potential adverse effects of inhaled
corticosteroids on voice both with regard to onset of abnormalities and with regard to
magnitude of effects.
This pilot study is an initial probe into clarifying the potential of the inhaled
corticosteroid, fluticasone propionate delivered in the Advair DISKUS device to produce oral
candidiasis and voice changes, and to determine the best measurement to quantitate
objectively that effect.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male or Female, 18-55 years of age. Females will be eligible only if they are:
1. Surgically sterilized, post-menopausal, abstinent, or practicing adequate method
of birth control, and if they have a
2. Negative urine pregnancy test (females of childbearing potential)
2. History of mild persistent asthma for at least 6 months as defined by NIH NHLBI April
19971
At Visit 1 (Screening) treatment for the last 30 days prior to screening must be:
- No inhaled corticosteroid therapy. (Previous use of leukotriene receptor antagonists,
and/or cromones, in addition to bronchodilators also allowed.)
Exclusion Criteria:
1. Female subjects who are pregnant or trying to become pregnant
2. Breast feeding
3. Current patient reported hoarseness or sore throat
4. Presence of oropharyngeal thrush (as determined by investigator examination without
culture results)
5. Unresolved fungal, viral or bacterial infection elsewhere in the body
6. Viral or bacterial respiratory tract infection within the last 14 days
7. History of persistent gastro-esophageal reflux refractory to conventional treatment
within the last 30 days
8. Has smoked within the previous 6 months or has greater than a lifetime 10 pack-year
smoking history or regular exposure to environmental tobacco smoke
9. History of inflammatory arthritis requiring immunosuppressive or corticosteroid
therapy
10. History of glaucoma, cataracts (lens opacities), retinal disease, or blindness
11. Any serious concomitant disease such as cancer or serious renal, hepatic, cardiac,
immunodeficiency, neurological, psychiatric, or other disease
12. Any medical condition that, in the judgment of the investigator, might interfere with
the study, require treatment or make implementation of the protocol or interpretation
of the study results difficult
13. Active or quiescent tuberculosis infections of the respiratory tract
14. History of chronic bronchitis, COPD or emphysema
15. History of alcohol abuse (more than 2 drinks/day on average) or drug abuse within the
past 2 years
16. History within the last 2 years of moderate asthma requiring prednisone on more than
two occasions per year
17. Treatment with any investigational drug within the past 30 days
18. More than 1 short (less than 2 weeks) course of systemic corticosteroids in the
previous year prior to screening (Visit 1) or have had systemic corticosteroids in
the past pervious 2 months prior to Visit 1.
19. Subjects can be on maintenance immunotherapy but cannot have begun an immunotherapy
regimen or have had a change in their immunotherapy regimen within 30 days prior to
screening (Visit 1).
20. Subjects may be on intranasal steroid if it has been maintained for 4 weeks prior to
screen and a constant stable dose is maintained for the duration of the trial.
Locations and Contacts
Allergy & Asthma Medical Group & Research Center, San Diego, California 92123, United States
Additional Information
Starting date: August 2005
Last updated: January 30, 2006
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